Telephone: 086 1070950
Software Quality Engineer
Our client, a medical device company in Galway is currently looking to recruit a Software Quality Engineer for their site.
- Lead Quality and Compliance activities in relation to Software projects.
- Support, guide, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, as well as make recommendations on the adoption of industry best-practices.
- Ensure that company processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
- Collaborate with project teams to set determine the validation strategy and plan for execution.
- Quality reviewer on all computer systems validation documentation and system supporting documentation.
- Author computer system validation documentation; test scripts, protocols, reports,
- Pre and post-execution approval for all validation test scripts
- Review and approval of deviations arising from computer system validation activities. Provide input into addressing deviations and approval of deviation outcome.
Duties specific to ERP implementation project;
- Responsible for the accuracy of completeness of static and dynamic data relating to QA/RA functionality.
- Responsible for determining system parameters & Code Tables relating to QA/RA functionality.
- Responsible for preparation of specifications, implementation and testing of ERP system-generated documentation related to QA/RA functionality, e.g. labels, forms, reports.
- Responsible for definition and control of audit logs and electronic signatures.
- Test and where applicable design and implement enhancements to software system in conjunction with the software vendor to ensure the business needs are met.
- Author computer system training guides and operating instructions for QA/RA functionality.
- Work with QA/RA staff to implement changes to business processes and related SOPs to accommodate ERP functionality.
- Author new SOPs and Work Instructions relating to new ERP functionality.
- Provide training to QA/RA staff in the use of system functionality.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate effectively with all levels of the company.
- Ability to meet deadlines and follow through on assigned deliverables.
- Attention to detail.
- Proficiency in use of desktop software applications such as MS Office
Education / Experience
- BSc. degree in Computer Science or Quality Assurance, or equivalent industrial experience with Computer Software Validation within the medical device industry, of which at least two years must be within a quality assurance or related role.
- Experience of implementation and validation ERP business systems is desired.
- Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Part11 and Part 820.
- Familiarity with GAMP5 Guideline for ‘Risk-Based approach to GxP Compliant Computerised systems.
- Familiarity with Agile practices for software implementation and product development, particularly SCRUM.
For further information on this Software Quality Engineer role in Galway please contact Karl Lippett on 086 1070950 / firstname.lastname@example.org
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